News and Educations

New review of valproate use in pregnancy and women of childbearing age

13.03.2017

The European Medicines Agency (EMA) has started a new review looking at the use of valproate-containing medicines in the treatment of women and girls who are pregnant or of childbearing age. These medicines are approved nationally in member states of the European Union (EU), and have been previously reviewed at the EU level. Valproate has been authorised in the Republic of Croatia in the treatment of epilepsy and bipolar disorder.

An EMA review in 2014 resulted in measures to strengthen the warnings and restrictions on the use of valproate medicines in women and girls, due to the risk of malformations and developmental problems in babies who are exposed to valproate in the womb. Although sometimes there may be no alternative to using valproate, these measures aimed to ensure that patients are aware of the risks of doing so, and that they take valproate only when clearly necessary. The 2014 review also recommended studies at the EU level to measure how effective the proposed measures were. More information on the 2014 review is available here.

Some EU member states have since carried out additional assessments of the impact of the measures at national level and concerns have been raised about how effective the measures have been in increasing awareness and reducing valproate use appropriately. The French medicines regulator therefore asked EMA to review the effectiveness of the measures and to consider whether further EU-wide action should be recommended to minimise the risks in women who are pregnant or of childbearing age.

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will examine the available evidence and will consult with relevant stakeholder groups. This will include holding a public hearing about their concerns. While the review is ongoing, patients prescribed valproate who have any concerns or questions about their medication should discuss them with their doctor.

More about the medicine

Valproate medicines are used to treat epilepsy and bipolar disorder. In some EU Member States they are also authorised to prevent migraine headaches.

The active ingredient in these medicines may be valproic acid, magnesium valproate, sodium valproate, valproate semisodium or valpromide.

The review of valproate was initiated at the request of France under Article 31 of Directive 2001/83/EC.

The review will be carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations. The PRAC recommendations will then be sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which will adopt the final position. The CMDh is a body representing EU Member States as well as Iceland, Liechtenstein and Norway. It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.